Download to our intergel information package

Parker & Waichman, LLP Attorneys at Law
Intergel Information Guide
The Case Against Intergel:
Manufacturer:
Johnson & Johnson
Date Approved:
November 2001
Status:
Withdrawn 3/27/03
Approved Uses:
Gynecological surgery
Serious Side Effects:
Infertility
Severe pelvic pain
Repeat surgeries
Scarring
Death
Related Topics:
Interceed
Defective Drugs
Intergel is a thick liquid gel made of sodium hyaluronate and iron.
It is used during gynecological surgery to disconnect and
safeguard tissues as they heal, preventing adhesions. The gel is
supplied in a sterile, single-use bottle. The product was developed
in a collaborative effort between Lifecore Biomedical and
Gynecare, a branch of Ethicon, a Johnson & Johnson company.
The FDA originally turned down approval for Intergel in 2000,
concluding that administering the gel raised a woman’s risk of
infection. Upon this rejection, Gynecare filed an appeal and in
November 2001 Intergel was considered convincingly safe by the
FDA. Nearly a year later, the FDA’s doubts were illustrated when
the product was withdrawn from the market after more than 100
reports showed that the use of Gynecare Intergel led to serious
health problems including reported infertility, severe pelvic pain,
repeat surgeries, scarring, and death.
On March 27, 2003, Lifecore voluntarily withdrew Intergel from the
market and suspending global sales to assess information
obtained from post marketing experience with the product.
To this date, the Food & Drug Administration (FDA) has received
72 reports of adverse events, including three deaths and 48
injuries in the United States of patients who where treated with
Lifecore’s Intergel.
The gel had also been used in certain off-label uses, which were
not specifically approved and in some cases warned against,
including: Laparoscopic surgery, Hysterectomy, and certain
intestine-related procedures.
If you or a loved one has been injured by Intergel, Parker &
Waichman, LLP will evaluate your case for free. Click here for a
free, no obligation, case evaluation.